Recast symposium

Brussels – 23 May 2017 – afternoon

On Tuesday afternoon of the 23rd of May 2017 the FAMHP, as the competent authority, will organise a symposium with the official information hot off the press about the recast.

Everyone who is interested in the domain of medical devices is invited.

An interesting programme with experts such as Valérie Nys (FAMHP, Anne Van Nerom (ISP) and Richard Van den Broeck (FAMHP) has been put together. The regulatory aspects as well as practical consequences for medical devices in general and in-vitro diagnostics in particular will be discussed and there will also be information about the impact on the Medical Technologies Pact.

Register for free at RecastMeddev@fagg-afmps.be. Attention, limited places available so be sure to register on time. More information will follow.

News

As previously reported, the FAMHP has started a pilot for clinical trials in Belgium in collaboration with the new college charged with designation the ethics committee for the evaluation of clinical trials, the current ethics committees and sponsors of clinical trials.

All tissue establishments in Europe, including the ones located in Belgium, can from now on be found through a new compendium.

As from the  7th of February, new version of the electronic application form are available. For more details please go to the esubmission webpage of EMA.

The Federal Agency for Medicines and Health Products was created in 2007. In 2017 we celebrate our ten year anniversary.

In October 2018 the new clinical trial regulation 536/2014 (CTR) is foreseen to enter into force. This important change in legislation targets administrative simplification and harmonization in Europe.

The Heads of Medicines Agencies (HMA) has published a statement of intent related to the replacement of the eAFs by the CESSP. As outlined in the eSubmission Roadmap, the current Common European Submission Platform (CESP) and the EMA eSubmission Gateway will be integrated into a Single Submission Portal. This single portal shall be built on the current CESP. This future system is meanwhile referred to as the Common European Single Submission Portal (CESSP).

During the Christmas holidays, famhp will be closed from Monday 26 December 2016 until Friday 30 December 2016 included.

The unit Scientific-Technical Advice & Knowledge Management has the pleasure to invite all those who are interested to the morning workshop “Famhp & EMA initiatives to support innovative drug development: implementation of a National Innovation Office as part of the EU Innovation Network” organised by the federal agency for medicines & healthcare products (famhp) on Thursday 01/12/2016. This interactive workshop will be held at famhp’s offices in Brussels and is free of charge..

Last updated on 23/09/2015